U.S. Food and Drug Administration staff on Tuesday said Pfizer’s (NYSE:PFE) clinical trial results on its COVID antiviral pill Paxlovid support the drug’s use in adults at high risk of progressing to severe disease.
The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday, when external advisors on the agency’s Antimicrobial Drugs Advisory Committee will discuss whether to recommend full approval of Paxlovid for the treatment of mild to moderate COVID in high-risk adults.
At the meeting, advisers will consider evidence related to Paxlovid’s efficacy, and vote on whether the benefits outweigh the risks of using the drug. The FDA typically follows the advice of its advisory committees but is not required to do so.
The FDA authorized Paxlovid for emergency use in December 2021. Pfizer submitted an application for full approval of the drug in June 2022, and the FDA extended the review period of the application in December 2022. The agency is set to complete its review in May.
The meeting comes as companies like Pfizer and Moderna (NASDAQ:MRNA) brace for a drop in sales of COVID vaccines and treatments that led to record revenues earlier in the pandemic. Sales of Paxlovid jumped to $18.9 billion in 2022, the first year it was available, but the company said it expects that revenue to drop 58% to $8 billion this year.
More than 12 million courses of Paxlovid have been delivered to pharmacies across the U.S., according to federal data. Roughly eight million Americans have taken the drug, with about 1.3 million doses available nationwide.
PFE shares dipped 19 cents to $39.71.
